The present invention relates generally to medical and therapeutic devices and, more particularly, to devices for regulating the temperature and applied pressure to body tissue. The present invention is particularly suited for use in closing cuts, punctures and incisions in the femoral artery incident to arterial access procedures.
The femoral artery is a preferred access site of arterial catheters and other devices inserted into the cardiovascular system for inspection and surgical procedures. Generally speaking, that artery is initially cut, punctured or otherwise opened to allow devices to be inserted into and along the artery for certain lengths. When the device is removed, the opening in the artery must be closed and sealed quickly and efficiently. There is considerable variance in the difficulty of this closure, depending, for example, upon the physical condition of the patient.
Properly done, the artery opening is closed and compressed just sufficiently to stop bleeding, but not compressed so far as to significantly constrict the flow of blood downstream of the artery opening. Often, this compression must be maintained for a considerable length of time in order for the healing process to progress sufficiently especially where the patient's blood has been subject to anti-clotting treatment incident to the surgery. Previously, this closure procedure has been done manually by a nurse applying pressure through his or her fingers while immersed in an ice field about the artery opening. In addition to lacking sterility and precision, on occasion this manual pressure must be maintained for several hours, effectively immobilizing the nurse along with the patient and being an extremely uncomfortable experience for the nurse.
Various apparatus have been suggested as alternative procedures, but each of these has had significant drawbacks. For example, bovine collagen patches will provide instant coagulation but require precise placement on the artery or else it will introduce blood clots into the blood stream. In addition to thus producing a major health risk, these patches tend to be relatively expensive.
Other apparatus are known which permit normal coagulation over extended lengths of time, but lack reliability and precise control over the amount of compression applied. For example, it has been suggested to apply various rigid clamps to the patient to provide consistent arterial pressure. However, such clamps require complete patient immobility over an extended period of time to avoid leakage and, thus, can be extremely uncomfortable for the patient. Further, such clamps fail to fully accommodate the normal pulsating motion of the artery itself. Various flexible corsets or belts have also been suggested, but these often require careful installation prior to surgery, are uncomfortable for the patient to wear for long periods of time, restrict patient transfer, preclude optimum application of ice or cold compresses, provide only an arbitrary pressure based upon component elasticity and/or substantially block visibility of the artery vicinity.
Accordingly, it is an object of this invention to provide a new and improved apparatus and method for femoral artery compression, including a device which:
1. is inexpensive to manufacture, PA1 2. is minimally restrictive to visibility of the puncture area, PA1 3. accommodates patient movement without significant loss of compression, PA1 4. is comfortable for the patient to wear for extended periods of time, PA1 5. provides precise pressure at a fixed location, PA1 6. is readily adjustable with respect to applied pressure, PA1 7. permits adequate application of pressure and reduced temperature without constant involvement of hospital staff, PA1 8. is sterile and easy to install after the operation, and PA1 9. is constructed of familiar components so as to be user friendly as well as easy to repair and adjust.
These and other objects of the present invention are attained by the provision of an apparatus for femoral artery compression having an inflatable bladder, a cooling member and a rigid panel disposed within a sterile envelope and securable to a patient about the wound site via a detachable strap. The envelope can be precooled as a unit and located over the wound such that the rigid panel focuses compressive force against the artery, trapping it between the panel and the pelvic bone rim. The bladder is adjustably inflatable by a conventional squeeze bulb valve arrangement and forces the cooling member against the rigid panel and the tissue in the wound vicinity. The rigid panel includes ridge structure to restrict sliding movement with respect to the cooling member. The envelope includes separate chambers for each of these components so as to restrict their movement once the envelope has been properly positioned. The envelope and its components are preferably constructed from inexpensive materials such that the entire apparatus is conveniently disposable after a single use.
Other objects, advantages and novel features of the present invention will now be readily apparent to those of skill in the art from the attached drawings and detailed description below.